FDA Regulator’s Testimony Deemed Irrelevant as Medical Device Expertise

Wendy Ketner, M.D.

Written by
— Updated on March 3, 2020

FDA Regulator’s Testimony Deemed Irrelevant as Medical Device Expertise

Court: United States District Court for the Eastern District of Pennsylvania
Jurisdiction: Federal
Case Name: Ctr. City Periodontists, P.C. v. Dentsply Int’l, Inc.
Citation: 2017 U.S. Dist. LEXIS 115373

Facts

The plaintiffs, a group of dental professionals, brought a class action suit against the defendant, a medical device manufacturer. The suit alleged a violation of the express warranty claims for a device developed, marketed, and sold across the U.S. The plaintiffs claimed the device, a medical device for use in dental procedures both below and above the gum line, was not suitable for its intended use. They argued that when used as directed, biofilm accumulated on the device’s water lines. This exposed patients to potentially hazardous levels of bacteria above safe water standards. The plaintiffs retained a medical device expert witness to testify on the regulations that apply to the medical device.

The Medical Device Expert Witness

The medical device expert witness was a former U.S. FDA administrator. He graduated with a degree in microbiology with an emphasis on biomedical engineering. He also completed a postgraduate degree in physiology. He had over 36 years of extensive experience with FDA regulatory compliance procedures and biomedical device-related issues. His area of study included the regulatory requirements of the FDA with respect to medical devices and the methods of infection control practiced in the field. The medical device expert witness submitted a report on the regulatory protocols applicable to the device. The defendants challenged the expert’s report under Daubert.

Discussion

The court decided that the medical device expert witness was suitably qualified to testify under Daubert. The court further asserted that the expert’s opinion, based on his education, training, and experience, was sufficiently reliable. However, the court asserted that the main legal issue at hand was whether the device’s directions for use (DFUs) included an express warranty of safety and whether this had been infringed. In light of this, the court stated that they must decide whether the medical device expert’s report covered the relevant factual issues.

The court ruled that the medical device expert’s opinion on regulatory requirements with regard to the device was irrelevant. They discussed this was because the issue of express warranty would depend on the device’s specific DFU language rather than the larger industry regulations. Since the expert had no knowledge of class certification nor had he addressed the specific DFU’s, his opinion could not be used reliably in this matter.

Further, the court rejected the plaintiff’s argument that the medical device expert’s testimony helped demonstrate Rule 23’s commonality, typicality, and predominance requirements. The plaintiff argued that the expert’s testimony showed the DFU’s consistent incorrectness. However, the court noted that the plaintiffs were unable to quote any case in which a court accepted a regulatory expert’s testimony on a breach of warranty claim.

Held

Defendant’s motion to exclude the testimony of the plaintiff’s medical device expert witness was granted.

Find a Medical Device Expert Witness Near You

What State is your case in?

AL AK AZ AR CA CO CT DE DC FL GA HI ID IL IN IA KS KY LA ME MD MA MI MN MS MO MT NE NV NH NJ NM NY NC ND OH OK OR PA RI SC SD TN TX UT VT VA WA WV WI WY